Catheter for monitoring intrauterine pressure to protect the fallopian tubes

ABSTRACT

A multi-lumen catheter for monitoring intrauterine pressure comprising an elongated body configured and dimensioned for insertion into a uterus of a patient, the catheter having a first lumen, a second lumen, and a first balloon at a distal portion. The first lumen communicates with the first balloon and the second lumen has an opening within the uterus for injection of x-ray dye or other fluid into the uterus for imaging the uterine cavity and the fallopian tubes of a patient. The first balloon contains a gas to form along with the first lumen a chamber to monitor pressure within the uterus to thereby determine if excessive pressure is being applied to the fallopian tubes of the patient. A sensor is in communication with the first lumen to measure pressure about a circumferential area of the balloon to measure pressure in the uterus to provide readings of intrauterine pressure.

This application claims priority from provisional application Ser. No.62/590,513, filed Nov. 24, 2017 and is a continuation in part ofapplication Ser. No. 15/949,022, filed Apr. 20, 2018 which claims thebenefit of provisional application Ser. No. 62/544,690, filed Aug. 11,2017, provisional application Ser. No. 62/514,793, filed Jun. 3, 2017,provisional application Ser. No. 62/590,513, filed Nov. 24, 2017 andprovisional application Ser. No. 62/622,871, filed Jan. 27, 2018. Theentire contents of each of these applications are incorporated herein byreference.

BACKGROUND OF THE INVENTION 1. Field of the Invention

This application relates to a device and method for monitoring ormeasuring intrauterine pressure exerted in the fallopian tube duringHysterosalpingogram (HSG), Sonohysterogram (SHG),Hysterosalpingo-contrast sonography (HyCoSy) or Saline Infused Sonogram(SIS) so as to protect the fallopian tubes while determining patency.

2. Background

During Hysterosalpingogram (HSG), Sonohysterogram (SHG),Hysterosalpingo-contrast sonography (HyCoSy) or Saline Infused Sonogram(SIS) procedures unrecognized excess pressure in the uterine cavity canlead to extravasation of the dye or the fluid into the uterinevasculature. This unrecognized excess pressure can also damage thefallopian tubes.

A hysterosalpingogram or “HSG” is an X-ray procedure to examine theuterus and fallopian tubes via injection of a radiographic dye. It is acommon diagnostic test performed during evaluation of female fertility.It is usually performed in the radiology department of a hospital oroutpatient radiology facility, in which radiographic dye is injectedinto the uterus through the cervix. The uterus fills with dye which, ifthe fallopian tubes are open, fills the tubes and spills into theabdominal cavity. This shows whether the fallopian tubes are open orblocked, as well as the location of any blockage. The HSG, however, hasa major shortcoming in that it is not data-driven. In a study of 325infertile patients, researchers measured the pressure at which dyepassed through the fallopian tubes (“tubal perfusion pressure”) andfound that the lower tubal perfusion pressure was correlated with ahigher fertility rates, thereby suggesting the importance of improvingclinical understanding of the relationship between tubal perfusionpressure and fertility. Existing HSG catheters, such as the CooperSurgical HGS/HS catheter Set and the Utah Medical Trans-VaginalUltrasound HSG catheter, however, are merely conduits for theradiographic dye injected into the uterus. They do not provideinformation about the intra-uterine pressure as dye fills the uterinecavity. Moreover, since they provide no information regarding pressuregenerated during the procedure, the excess pressure can cause dye to getpushed into the fragile uterine vasculature especially if the fallopiantubes are blocked due to disease. If the fallopian tubes are noted to bepatent during the procedure than it would be beneficial to know thepressure generated in the uterus during the process. As noted earlier,the lower pressure correlates with increased chance or spontaneousfertility when fallopian tubes are noted to be patent. All in all it isbeneficial to know the intrauterine pressure generated during theseprocedures so as to protect the uterus and the fallopian tubes.

A sonohysterogram is an ultrasound exam in which fluid is put into theuterus through the cervix (like an HSG) and sound waves are used tocreate images of the uterine cavity and fluid spillage from thefallopian tube. Saline infused Sonogram (SIS) is a test where saline isinserted into the uterus, allowing the uterine lining (endometrium) oruterine cavity to be seen. Both of these procedures are a special kindof ultrasound exam in which fluid is put into the uterus and sound wavesare used to create images of the uterine lining or the uterine cavity.The fluid helps show more detail than when ultrasound is used alone.Although HSG is still widely used as a first-line procedure forevaluating female infertility, ultrasound imaging advances have led toSIS and hysterosalpingo-contrast sonography (HyCoSy) replacing HSG inmany centers around the world.

Determination of the tubal patency is essential for diagnosis of femaleinfertility. In general, infertility is defined as not being able to getpregnant after one year of unprotected sex. According to the CDC, about6% of US married women aged 15-44 years are unable to get pregnant afterone year of trying; and about 12% of US women regardless of maritalstatus aged 15-44 years have difficulty getting pregnant or carrying apregnancy to term. It is estimated that in the U.S. alone over 480,000women struggle to conceive each year.

Determination of the tubal patency is also required by the FDA after anEssure procedure for confirmation of tubal occlusion. There are varioustubal occlusion procedures elected by a patient to prevent conceptionsuch as the Essure procedure in which a soft, flexible insert is placedinto each fallopian tube, and a barrier subsequently forms around theinserts; or a surgical procedure in which the fallopian tubes areclamped and blocked, or severed and sealed, to prevent eggs fromreaching the uterus.

Although the foregoing procedures/devices effectively image the flow ofdye to determine whether the fallopian tubes are blocked or open, theseprocedures do not provide any way to protect the uterus or the fallopiantubes from damage during the procedure as described above. It wouldtherefore be advantageous to provide a device which not only determinesthe tubal patency but also prevents exertion of excess force in theuterine cavity which may damage the fallopian tubes during the imagingprocedure. Too much pressure could also blow open a tract in theoccluded fallopian tubes leading to increased risk of ectopic pregnancyand or unwanted pregnancy. More importantly, it would be advantageous toknow how much pressure is exerted in the uterus when the fluid runsthrough the fallopian tubes and noted to spill into the abdominalcavity.

SUMMARY

There are numerous procedures which utilize insertion of dye into theuterus and fallopian tubes and followed by imaging via X-ray orultrasound. These procedures are used to diagnose infertility and todiagnose efficacy of the permanent birth control by determination if thefallopian tubes are patent. However, if the dye is injected, especiallyin a case where the fallopian tubes are not sufficiently open or areclosed, excess pressure can be exerted on the fallopian tubes causingdamage to the tubes and is seen readily by dye extravasating into theblood vessels around the uterus and the fallopian tubes. Excess pressureexerted during the procedure can also cause severe and prolonged paindue to the damaged tubes. The present invention provides a device tomeasure the intrauterine pressure in the uterus and the fallopian tubesduring HSG, SHG, HyCoSy, or SIS procedures or other procedures. Inaddition the device can help protect and reduce the risk of harm to theuterus and the fallopian tubes. This is accomplished by an accuratepressure monitoring system which can determine the pressure within theuterus since closed fallopian tubes would cause unwanted pressure by thedye within the uterus. The present invention therefore overcomes thedeficiencies and disadvantages of the prior art. The physician canaccurately apply specific amount of pressure in the uterus to determinethe opening pressure of the patent fallopian tubes and protect theuterus from unrecognized excess pressure generated when fallopian tubesare occluded.

The catheters of the present invention utilize an air-charged chamber ora micro-tip sensor to measure intrauterine pressure and enable pressureto be measured continuously if desired. Various types of sensors anddifferent locations of the sensors are utilized with the severalembodiments of the catheters of the present invention. Each of thesevarious embodiments is discussed in detail herein.

Some embodiments of the catheter of the present invention include ablocking member to block the outflow of dye from the uterus. Theseembodiments are discussed in more detail below.

In accordance with one aspect of the present invention, a multi-lumencatheter for monitoring intrauterine pressure to prevent damage to thefallopian tubes is provided. The catheter comprises an elongated bodyconfigured and dimensioned for insertion into a uterus of a patient, thecatheter having a first lumen, a second lumen, and a first balloon at adistal portion. The first lumen communicates with the first balloon, andthe second lumen has an opening within the uterus for injection of dyeor other fluid into the uterus. The first balloon contains a gas to formalong with the first lumen a gas containing chamber to monitor pressurewithin the uterus to thereby prevent excessive pressure applied to thefallopian tubes of the patient. A sensor is in communication with thefirst lumen to measure pressure about a circumferential area of thefirst balloon to measure pressure, preferably continuously, of theuterus to provide readings of intrauterine pressure.

In accordance with another aspect of the present invention, amulti-lumen catheter for monitoring intra uterine pressure to preventdamage to the fallopian tubes of a patient is provided. The cathetercomprises an elongated body configured and dimensioned for insertioninto a uterus of a patient, the catheter having a first lumen, a secondlumen and a pressure sensor. The pressure sensor is positioned within adistal region of the first lumen, the second lumen having an openingwithin the uterus for injection of dye or other fluid into the uterus,and the sensor monitoring pressure within the uterus to thereby ensurepressure in the fallopian tubes of the patient does not exceed apredetermined pressure. In accordance with another aspect of the presentinvention, a multi-lumen catheter for monitoring intrauterine pressureto prevent damage to fallopian tubes of a patient is provided. Thecatheter is configured and dimensioned for insertion into a uterus of apatient. The catheter comprises a first lumen, a second lumen, anexpandable outer balloon at a distal portion and an expandable innerballoon within the outer balloon, the first lumen communicating with theinner balloon and the second lumen communicating with the uterus toinject dye or other fluid into the uterus for imaging. The inner balloonand first lumen contain a gas to form a gas containing chamber tomonitor pressure within the uterus to determine if pressure exceeds athreshold pressure which could damage the fallopian tubes of thepatient. The outer balloon has a circumferential area greater than acircumferential area of the inner balloon, wherein in response topressure within the uterus exerted on an outer wall of the outerballoon, the outer balloon deforms and exerts a pressure on an outerwall of the inner balloon to deform the inner balloon and compress thegas within the inner balloon and the first lumen to provide a finermeasurement, the pressure sensor measuring intrauterine pressure basedon gas compression caused by deformation of the inner balloon.

In accordance with another aspect of the present invention, a method fordetermining a condition of fallopian tubes and for measuringintrauterine pressure is provided comprising the steps of:

providing a catheter having first and second lumens and an expandablefirst balloon in communication with the first lumen,

inserting the catheter into a uterus of a patient;

connecting a hub containing a pressure transducer to the first lumen toautomatically advance air through the first lumen of the catheter toexpand the first balloon to a more expanded condition;

injecting dye or other fluid through the second lumen into the uterus toassess an open or closed condition of the fallopian tubes;

obtaining a first pressure reading of the uterus based on deformation ofthe first balloon in response to pressure exerted on the first balloon;and

transmitting the first pressure reading to an external monitor connectedto the hub to indicate pressure, the indicated pressure indicative ofpressure exceeding a threshold pressure which could damage the fallopiantubes.

BRIEF DESCRIPTION OF THE DRAWINGS

So that those having ordinary skill in the art to which the subjectinvention appertains will more readily understand how to make and usethe surgical apparatus disclosed herein, preferred embodiments thereofwill be described in detail hereinbelow with reference to the drawings,wherein:

FIG. 1A is a side view of a first embodiment of the catheter of thepresent invention having a pressure sensing balloon, the balloon shownin the inflated (expanded) condition;

FIG. 1B is a transverse cross-sectional view of the catheter of FIG. 1A;

FIGS. 2A and 2B are close up views of the catheter of FIG. 1A;

FIG. 3 is a schematic view of the system utilizing the catheter of FIG.1A with an alarm system;

FIG. 4A is a side view of an alternate embodiment of the catheter of thepresent invention;

FIG. 4B is a transverse cross-sectional view of the catheter of FIG. 4A;

FIG. 4C is a close-up view of the sensor of the catheter of FIG. 4A;

FIG. 5A is a side view of another alternate embodiment of the presentinvention having a slidable stopper;

FIG. 5B is a side view of another alternate embodiment of the presentinvention having a stopper attached to a slidable sheath;

FIG. 6 is a side view of an alternate embodiment of the presentinvention having an external transducer;

FIG. 7A is a side view of the distal region of a catheter of analternate embodiment of the present invention having an outer and innerpressure balloon and a retention balloon, the balloons shown in theinflated condition;

FIG. 7B is a transverse cross-sectional view of the catheter of FIG. 7A;

FIG. 8 is a side view of an alternate embodiment of the catheter of thepresent invention having a pressure balloon and a sealing memberslidable along the catheter, the balloon shown in the inflated(expanded) condition and further showing the external transducer;

FIG. 9 is a perspective view of the proximal end of the catheter of FIG.8 and the transducer hub prior to attachment to the catheter;

FIGS. 10A and 10B are cutaway side views showing the pressure transducerprior to connection to the catheter of FIG. 8, a portion of the hub walland catheter connector removed to show internal components;

FIG. 11 is a side view showing the transducer hub attached to thecatheter of FIG. 8;

FIG. 12 is a schematic view of an alternate embodiment of the pressuretransducer hub connectable to two side ports of the catheter;

FIG. 13A is a perspective view of an alternate embodiment of thetransducer hub and connector;

FIG. 13B is a cutaway side view of the hub and connector of FIG. 13Ashowing the pressure transducer prior to connection to the catheter ofFIG. 13A, a portion of the hub wall and connector removed to showinternal components;

FIG. 13C is a cutaway side view similar to FIG. 13B showing the hubattached to the catheter; and

FIG. 13D is a cutaway side view similar to FIG. 13B from the other side.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The catheters of the present invention are designed to determine thecondition of the fallopian tubes, i.e., whether the fallopian tubes areopen or closed, in fertility and/or infertility procedures via dyeinjection while protecting the fallopian tubes to prevent damage to thefallopian tubes. More specifically, the catheters of the presentinvention are inserted through the vagina and cervix and into the uterusand enable a) injection of dye for imaging of the fallopian tubes viaX-ray, ultrasound or other methods; and b) continuously, safely, andaccurately measure intra-uterine pressure to ensure excess pressure isnot exerted on the fallopian tubes and/or the uterine muscle from thedye injection. More specifically, if the dye is injected, especially ina case where the fallopian tubes are not sufficiently open or areclosed, excess pressure can be exerted on the fallopian tubes causingdamage to the tubes. Excess pressure could also be exerted on theuterus. Thus, the catheters of the present invention measureintrauterine pressure as the dye fills the uterine cavity and monitorthe pressure: decreasing or plateauing intra-uterine pressure signifiesthe fallopian tubes are open; non-plateauing of intrauterine pressuresignifies the fallopian tubes are blocked and that too much pressure maybe exerted by the dye on the fallopian tubes and/or the uterine muscle.If too much pressure is exerted, it may be accompanied by visualpresentation of dye being pushed into the tubal blood vessels or uterinemuscle, causing extravasation of the x-ray dye or fluid leading topossible damage/allergic/anaphylaxis within the patient. Thus, thepresent invention provides a device/system and method to protect andreduce the risk of harm to the fallopian tubes and uterus whileperforming the diagnostic procedure. In preferred embodiments, constantmonitoring of pressure is provided so critical time periods are notmissed.

The present invention provides a multi-lumen catheter insertable throughthe vagina and cervix into the uterus in the same manner as a HSGcatheter. The catheters of the present invention utilize in someembodiments a gas (e.g., an air) charged chamber to measure uterinepressure across a large surface area. In other embodiments, thecatheters of the present invention utilize a microtip pressure sensor ata distal end of the catheter to measure uterine pressure. In eithercase, the sensor provides the doctor with real-time information on 1)increasing intra-uterine pressure as dye or fluid fills the uterinecavity; 2) decreasing or plateauing intra-uterine pressure; and/or 3)non-plateauing of intra-uterine pressure if the fallopian tubes areblocked. The pressure measurement can also assist physicians indetermining the normal opening pressure for the fallopian tubes.

The catheters of the present invention have a lumen to injectradiographic dye into the uterus for flow into the fallopian tubes toassess blockage of the fallopian tubes and a lumen for measuringintra-uterine pressure to assure the fallopian tubes are not damaged. Insome embodiments, the catheter can have a third lumen for inflation of aretention (stabilizing) and sealing balloon to block outflow of dye; inother embodiments the catheter has a sealing member, e.g., a stopper orcork, stationary or slidable on the catheter shaft, to block outflow ofdye and stabilize the thin flexible catheter to better enable insertioninto the uterine cavity. Each of these embodiments is discussed indetail below.

Referring now to the drawings and particular embodiments of the presentinvention wherein like reference numerals identify similar structuralfeatures of the devices disclosed herein, there is illustrated in FIG. 1a catheter of a first embodiment of the present invention. The catheter(device) is designated generally by reference numeral 10 and isconfigured for insertion into and positioning within the uterus of thepatient for injecting radiographic dye and measuring intrauterinepressure. The catheter can be connected to a handheld or bedside orcentral monitor through a wire (or cable) or blue tooth wirelessconnection to display continuous readings of the measured pressure.Opening pressure of the fallopian tubes could also be measured.

Turning now to details of the catheter 10, which is also referred toherein as the device 10, and with initial reference to FIGS. 1A-2B, thethree-lumen catheter 10 has an elongated flexible shaft 12 having alumen (channel) 14 extending within the shaft 12 and communicating atits distal region with balloon 16 to fluidly communicate with balloon 16to inflate the balloon. Balloon 16 is utilized for monitoring pressureand is sometimes referred to herein as the “pressure balloon.” A fluidside port 15 is positioned at a proximal region 17 of the catheter 10for communication with an infusion source for infusion of gas, e.g.,air, through the lumen 14 and into the balloon 16. The catheter 10 isshown in FIG. 1 with balloon 16 in the inflated condition (position) forpositioning within the uterus. It is inserted into the uterus in thedeflated (collapsed) condition.

The shaft 12 also includes a second lumen (channel) 24 with a proximalopening 20 a and a third lumen (channel) 24 extending therein. Thesecond lumen 24 is configured for insertion of radiographic dye for flowinto the uterus and fallopian tubes. The second lumen can have a distalopening and/or a side opening 20 b at a distal portion, communicatingwith the uterus. The side opening 20 b is shown distal of the balloon16; in alternate embodiments, the side opening can be proximal of theballoon 16. The third lumen 24 terminates at its distal end withinballoon 26 to fluidly communicate with balloon 26 to inflate the balloon26. The balloon 26 is inflatable to stabilize/retain the catheter 10 tolimit movement of the catheter 10 to keep it in place and is sometimesreferred to herein as “the stabilizing balloon” or “retention balloon.”The retention balloon is preferably sized to block the outflow of dyefrom the uterus and can therefore also function as a sealing balloon.Alternatively, a separate sealing balloon or sealing member could beprovided in addition to the stabilizing balloon. A fluid side port 28 ispositioned at the proximal region 17 of the catheter 10 forcommunication with an infusion source for infusion of fluid through thelumen 24 and into the stabilizing balloon 26. The balloon can be filledwith fluid, e.g., liquid such as water or saline, or a gas, e.g., air.In FIG. 1A, the balloon 26 is shown in the inflated condition and is inthe deflated (collapsed) condition during insertion of the catheter.

FIG. 1 is a transverse cross-section of the catheter showing the threelumens. The cross-sectional shapes and sizes of the lumens in thedrawings are provided by way of example as one or more of the lumens ofthe various catheter embodiments disclosed herein (including FIG. 1A)can be other shapes, e.g., circular, oval or other symmetrical orasymmetrical shapes in transverse cross section. This also applies tothe cross-sectional configurations of the lumens of the otherembodiments herein.

A sensor 30 is positioned within lumen 14 adjacent balloon 16. Thewire(s) 32 are shown extending through lumen 14, the sensor 30 andwire(s) 32 being of sufficiently small size so as not to interfere withgas, e.g., air, flow though lumen 14. The sensor 30 measuresintrauterine pressure. The sensor 30 is part of a transducer forconverting the variation in pressure to an electrical signal fortransmission to an external monitor. The transducer can be wireddirectly to the monitor or alternatively wired to a converter externalof the catheter for converting the signal received by the transducer andtransmitting a signal to the monitor, e.g., a bedside monitor, todisplay the pressure readings. This is shown schematically in FIG. 3.The readings can be displayed in quantitative form, graphical form orother displays to provide an indicator to the clinician of theintrauterine pressure. Alternatively, the sensor/transducer can beconnected to the monitor via a Bluetooth wireless connection.

Wires 32 can extend though lumen 14 and exit side port 15 for connectionto a converter or monitor or alternatively can be inserted through thelumen 14, piercing the wall to enter the lumen 14 distal of the sideport.

An indicator or alarm system can also be provided wherein the systemincludes a comparator for comparing the measured pressure to a threshold(predetermined) value, and if such threshold is exceeded, an indicator,e.g., an alarm, is triggered to indicate to the clinician the excessivepressure. An alarm system can alternatively or in addition be activatedif a change in pressure measurement exceeds a specified rate over aspecified period of time. This would alert the staff to an imminent riskof pressure exceeding a certain threshold or predetermined value(pressure). The indicator or alarm can be on (part of) the catheter oralternatively on an external device such as the monitor. The alarm canalso be connected via wireless connection to a phone or remote device toalert the appropriate personnel. Such indicator or alarm system can beutilized with the other embodiments disclosed herein. In embodimentswherein other parameters are measured, the alarm system described hereincan be tied into measurement of these parameters.

The lumen 14 and space within balloon 16 together form a closed gas,e.g., air chamber, i.e., the lumen 14 forming a gas column. With theballoon 16 filled with air (or other gas), pressure on the external wallof the balloon 16 will force the balloon to deform inwardly, therebycompressing the air contained within the balloon space and within thelumen 14. The pressure sensor 30 is located in a distal portion of thelumen 14 at the region of the balloon 16 and thus is positioned at thedistal end of the air column. Therefore, the pressure is sensed at thedistal region as the sensor 30 detects change in gas pressure in lumen14 due to balloon deformation. Placement of the sensor 30 at a distallocation provides a pressure reading closer to the source which in someapplications can increase the accuracy by reducing the risk oftransmission issues by reducing the amount of interference which couldoccur due to water, air, clots, tissue, etc. if the transmission is downthe air lumen (air column).

Additionally, the pressure measurement occurs about a morecircumferential area of the balloon 16 providing a pressure reading of aregion greater than a point pressure sensor reading. Also, averagepressure over an area of the uterine wall can be computed. Thus, thearea reading gleans information on pressure over more of the uterinewall. Stated another way, the balloon has a relatively large surfacearea with multiple reference points to contribute to average pressurereadings of the surface around it.

The air column is charged by insertion of air through the side port 15which communicates with lumen 14. The side port 15 includes a valve toprovide a seal to prevent escape of air from a proximal end. The balloon16 can be composed of impermeable material, or in alternativeembodiments, a permeable or semi-permeable material with an impermeablecoating. This seals the air column at the distal end to prevent escapeof air through the distal end, i.e., through the wall of the balloon 16.Thus, with the lumen sealed at the proximal end and the balloon sealedat the distal end, a closed air (or other gas) system (air chargedsystem) is provided.

In preferred embodiments, when the lumen 14 is air charged, the balloon16 is not fully inflated. This improves the accuracy of the balloon 16transmitting pressure from external the balloon to the interior of theballoon and into the lumen, i.e., air column, by ensuring the balloonhas sufficient compliancy to prevent the balloon from introducingartifact into the pressure reading which would diminish its accuracy.That is, in preferred embodiments, the pressure balloon 16 is not fullyinflated so it would receive less than the maximum volume. Thus, with aballoon of maximum X volume, the balloon would receive X-Y fluid, with Yrepresenting the amount of desired extra space to achieve desiredcompliancy of the balloon while still enabling sufficient inflation ofthe balloon to achieve its pressure induced deformation function. Thus,the use herein of gas or air filled chamber or balloon or lumen filledwith gas encompasses the balloon completely filled or partially filled.The term gas containing chamber is therefore also used herein.

Note in this embodiment, the stabilizing balloon 26, also referred to asthe proximal retention balloon, is positioned proximal of the pressureballoon 16. Also, in this embodiment, the stabilizing balloon 26 islarger than the pressure balloon 16. Alternatively, the stabilizingballoon can be smaller than the pressure balloon. Various shapes of theballoons are also contemplated.

It should be appreciated that although the stabilizing balloon is shownin the embodiment of FIG. 1, it is also contemplated as an alternative,the catheter and system of FIG. 1 can be utilized without thestabilizing balloon. Similarly, the various embodiments (catheter)disclosed herein could not include a stabilizing balloon or include astabilizing balloon. Also, it is contemplated that instead of astabilizing balloon another blocking member could be utilized asdiscussed below.

In the embodiment of FIGS. 4A-4C, catheter 40 has two lumens: 1) a lumen41 for injection of radiographic dye which has a proximal opening 45 anda distal opening 48 to communicate with the uterus (similar to lumen 20of FIG. 1); and 2) an air (or other gas) lumen 46 filling pressureballoon 44 (positioned at the distal end of shaft 43) via insertion ofair (or other gas) through side port 42. The cross-sectionalconfiguration of the lumens shown in FIG. 1B (and in FIG. 7B discussedbelow) are just two examples of the configuration as different sizes andshapes are also contemplated, e.g., circular, oval, symmetric,asymmetric, etc. The sensor is positioned within the air lumen in thesame manner as sensor 30 is in lumen 14 or in the alternative positionsdisclosed herein. Thus, the pressure sensing described in conjunctionwith FIG. 1 is fully applicable to the embodiment of FIG. 4A. Besidesthe elimination of the stabilizing balloon and its lumen and side port,catheter 40 is the same as catheter 10. Catheter 40 can in someembodiments have a plug such as plug 47 of catheter 40′ of FIG. 5A.Except for the plug 47, the catheter 40′ is identical to catheter 40 andcorresponding parts/components have been labeled with prime referencenumerals. The plug can be located outside the cervix in the vagina toblock outflow of dye. In the embodiment of FIG. 5B a sealing plug and aretention balloon are provided. More specifically, catheter 50 of FIG.5B has a pliable outer sheath 52 slidable over the catheter. The sheath52 can provide additional stability to the catheter. A tab 53 extendingfrom the sheath 52 at a proximal end can be provided to assist slidingof the sheath 52 in proximal and distal directions, although other typesof handles or grips can be provided to facilitate sheath sliding. Asealing plug 54 extends from the sheath 52 at a distal end and can beconically shaped as shown, although other shapes are contemplated, tohelp seal the cervical os. A retention balloon 56 is positioned in theuterus to help retain the catheter 50, and in some embodiments canperform an additional sealing function. The distal tip 51 of thecatheter 50 has a side opening 53 for injecting fluid. The catheter 50includes a sensor (not shown) such as a microtip sensor, a pressureballoon or any of the sensors disclosed herein. Note the sliding sheathwith seal can be utilized with any of the embodiments described herein.

Note that although only one sensor is shown in FIGS. 1 (and 4), it isalso contemplated that multiple sensors can be provided. Also, note thatthe sensor 30 is positioned in lumen 14 at a mid-portion of the balloon,i.e., just proximal where the opening in lumen 14 communicates with theinterior of the balloon 16. It is also contemplated that the sensor canbe placed at another portion within the lumen 14, e.g., a more proximalportion, with respect to the lumen opening. Also, the lumen opening neednot be at the mid portion of the balloon and can be at other regions ofthe balloon to communicate with the interior space of the balloon. Noteif multiple sensors are provided, they can be positioned at variouslocations within the lumen 14.

As shown, the sensor 30 and its transmission wires are located in thesame lumen 14 also used for inflation fluid, e.g., a liquid or a gassuch as air, for balloon 16 (or 44) and for the gas, e.g., air chargedcolumn. This minimizes the overall transverse cross-section (e.g.,diameter) of the catheter 10 by minimizing the number of lumens sinceadditional lumens require additional wall space of the catheter.However, it is also contemplated in alternate embodiments that thesensor is located in a dedicated lumen separate from the pressureballoon inflation lumen. This can be useful if a larger sensor oradditional wires are utilized which would restrict the air lumen ifprovided therein. This is also useful if a specific sized lumen for thesensor and wires is desired to be different than the sized lumen for theair column. Thus, in this embodiment, the catheter would have thefollowing lumens: 1) a lumen for injection of dye to communicate withthe uterus (similar to lumen 20 of FIG. 1); 2) a lumen for filling thepressure balloon; and 3) a lumen in which the sensor (similar to sensor30) and its transmission wires (similar to wires 32) are contained; andif the catheter includes a retention balloon, a fourth lumen for fillingthe retention balloon.

Turning now to the use of the catheter 10, the catheter 10 is insertedthrough the vagina and cervix into the uterus. Note the other catheters(e.g., catheter 40 and 40′) would be used in the same manner. Theballoon 26 is inflated to secure the catheter 10 in place during theprocedure by insertion of a fluid (liquid or gas) through side port 28which is in fluid communication with lumen 24. The inflated balloon 26also blocks the outflow of dye. The system is charged by inflation ofthe balloon 16, i.e., preferably partial inflation for the reasonsdiscussed above, by insertion of air (or other gas) via a syringe orother inflation device through port 15 which is in fluid communicationwith lumen 14. As discussed above, the catheter 10 is a closed systemwith the balloon 16 sealed so that air (or other gas) inserted throughlumen 14 and into balloon 16 cannot escape through balloon 16. Thus, aclosed chamber is formed comprising the internal space of the balloon 16and the internal lumen 14 communicating with the internal space. Withthe balloon 16 inflated, dye is injected through the lumen 20 exitingopening 20 b and pressure monitoring commences. When external pressureis applied to an outer surface of the balloon 16, caused by outwarduterine pressure against the wall of balloon 16 due to the presence ofdye, the gas within the chamber is compressed. The sensor 30 at thedistal end of lumen 14 provides continuous pressure readings, convertedto an electrical signal by the transducer within the distal end of lumen14, and then electrically communicates through wire(s) 32 extendingthrough lumen 14, exiting through the proximal side port 15 andconnected to an external monitor. This enables determination of thepressure inside the uterus to ensure it does not reach a level (apredetermined level or threshold) where it could damage the uterus orthe fallopian tubes into which the dye flows. Note the wire(s) canterminate at the proximal end in a plug in connector which can beconnected directly to the monitor or alternatively plugged into aconverter to convert the signals from the transducer in the embodimentswherein the converter is interposed between the wires and monitor (seee.g., the system of FIG. 3) to provide the aforedescribed graphicdisplay. Although, the system is capable of continuous pressuremonitoring, it can also be adapted if desired for periodic monitoring sothe pressure readings can be taken at intervals or on demand by theclinician.

In the embodiments wherein an indicator is provided, if the measuredpressure exceeds a threshold value, and/or a change in pressuremeasurement exceeds a specific rate over a specific time period, theindicator would alert the clinician, e.g., via a visual indication or anaudible indication, that the threshold is exceeded. The indicator insome embodiments can include an audible or visual alarm (shownschematically in FIG. 3). In the embodiments having an indicator, theindicator can be provided on a proximal end of the catheter whichextends out of the patient or the indicator can be part of an externalcomponent such as the monitor or a separate alarm system. A visual,audible, or other indicator can likewise be provided in any of the otherembodiments disclosed herein to indicate if the measured pressureexceeds a predetermined value, and such indicator can include an alarmand can be part of the catheter or a separate component.

In the alternate embodiment of FIG. 6, catheter 60 is identical to thecatheter 10 of FIG. 1A except that the pressure transducer is positionedexternal of the catheter rather than in the air lumen. That is, insteadof the pressure transducer including the sensor being positioned withinthe distal end of the air lumen, the pressure sensor is positionedwithin a lumen at the distal end of the lumen and transmission wire(s)connect the sensor to the pressure transducer 64 positioned outside ofthe patient at a proximal region 61 of catheter 60. As shown, thepressure transducer 64 can be positioned in a side port 65 of catheter60. In alternate embodiments, it is positioned outside the catheter. Inall other respects, catheter 60 is identical to catheter 10 andtherefore for brevity further discussion is not provided since thestructure and function of the pressure and stabilizing balloon(s) 62,63, plug (if provided), the lumens within shaft 66, the positioning ofthe sensors in the lumens, the continuous pressure monitoring, etc., aswell as the aforedescribed alternative arrangements of catheter 10, arefully applicable to the catheter 60.

In an alternate embodiment, the catheter is identical to catheter 60except that both the pressure transducer and the pressure sensor arepositioned external of the patient at a proximal region of the catheterrather than in the air lumen. That is, instead of the pressure sensorbeing positioned within and at the distal end of the air lumen, thetransducer and pressure sensor are positioned in a side port (like sideport 65). In yet other embodiments, the pressure sensor and/or pressuretransducer can be positioned within the air lumen at a proximal end ofthe air lumen. In either system, the system is charged by inflation ofthe balloon, i.e., preferably partially inflated for the reasonsdiscussed above, by insertion of air (or other gas) via a syringethrough the side port which is in fluid communication with the airlumen. The catheters like the aforementioned catheters are closedsystems with the balloon sealed so that air inserted through lumen andinto the balloon cannot escape through the balloon—a closed chamber isformed comprising the internal space of the balloon and the internallumen communicating with the internal space of the balloon. Pressureapplied against the balloon wall compresses the balloon and the gaswithin the chamber of the balloon, compressing the gas within the lumencreating a gas. e.g., air charged column along the lumen, with thesensor at the proximal end of the catheter measuring pressure of the gascolumn to provide continuous pressure readings, converted to anelectrical signal by the transducer at the proximal end or external ofthe catheter, and then electrically communicates through wire(s) to anexternal monitor. The balloon, like balloon 16 and the other pressureballoons described herein, is of sufficiently large size to provide asufficient circumferential area for detection of pressure changes alongseveral parts of the uterine wall, thereby providing an average pressureand enabling more accurate pressure readings. Note the wires of thesensor can terminate at the proximal end in a plug in connector whichcan be connected directly to the monitor or alternatively plugged into aconverter to convert the signals from the transducer in the embodimentswherein the converter is interposed between the wires and monitor toprovide the aforedescribed graphic display. Although, the system iscapable of continuous pressure monitoring, it can also be adapted ifdesired for periodic monitoring so the pressure readings can be taken atintervals or on demand by the clinician.

In an alternate embodiment, the catheter can include a pressure sensorwithin the balloon. That is, the pressure sensor is carried by thecatheter and positioned within the balloon to measure pressure inresponse to deformation of the balloon in response to pressure exertedon an outer wall of the balloon due to intrauterine pressure. Thepressure transducer can include a sensor or can be a separate componentpositioned at a proximal end of the catheter or external of the catheter

As discussed above, the pressure balloon has a large circumferentialarea (and large volume) to provide multiple reference points forpressure readings and to provide an average pressure to enable moreaccurate readings. Thus, the pressure balloon provides for grossmeasurement.

In an alternate embodiment shown in FIG. 7, the pressure balloon fordetecting pressure, designated by reference numeral 82, forms an outerballoon of catheter 80. Contained within the outer balloon 82 is aninner balloon 83. The inner balloon 83 provides a smaller diameterballoon and a smaller circumference (and volume) than the outer balloon82. The inner balloon 83 together with the lumen 84 forms a smaller aircolumn than in the embodiments discussed above where the larger ballooninternal space communicates directly with the air lumen. This providesfiner measurements. Thus, the compliant outer balloon 82 compresses thecompliant inner balloon 83 which compresses the air within air lumen 84.The closed system is thereby formed by the internal space of the innerballoon 83 and the lumen 84. In certain instances, the smaller balloonair column can provide a more accurate reading from the average pressuredetermined by the larger outer balloon 82.

The inner balloon 83 and outer balloon 82 can beseparately/independently inflated and closed with respect to each otherso there is no communication, e.g., passage, of gas or liquid, betweenthe inner and outer balloons 83, 82. The outer balloon can be filledwith a gas or liquid such as saline.

The proximal and distal end of the inner balloon 83 in the illustratedembodiment are within the confines of the outer balloon 82, i.e., theproximal end of the inner balloon 83 is distal of the proximal end ofthe outer balloon 82 and the distal end of the inner balloon 83 isproximal of the distal end of the outer balloon 82. Thus, the innerballoon 83 is fully encapsulated within the outer balloon 82.

With this inner/outer balloon arrangement, the larger outer surface ofthe outer balloon 82 takes gross measurements and then the forces areconcentrated on the smaller inner balloon to amplify/concentratepressure on the small area of the inner balloon so small changes can bedetected and waves transmitted to the pressure transducer (via thelength of the lumen to a proximal transducer, e.g. an externalpressure).

The pressure transducer and pressure sensor can be positioned within thelumen 84 in the same manner as sensor 30 of FIG. 1 and can function inthe same manner. Alternatively, the pressure transducer can be at aproximal end of the catheter 80 as in the embodiment of FIG. 6 orexternal of the catheter. The transmission wires of the pressure sensorextend through lumen 84.

The catheter 80 can optionally include a stabilizing (retention) balloon85 similar to balloon 26 of FIG. 1 which can also in some embodimentsblock proximal flow of the imaging dye. The catheter 80 would have alumen, e.g., lumen 86, to inflate the stabilizing balloon 85.Alternatively, the catheter 80 can have a plug such as plug 47 of FIG.5A which would block outflow of the dye, and in some embodiments, theplug can be slidable along the exterior of the catheter 80. Lumen 88with side opening 89 (or a distal opening) provides for outflow ofradiographic dye for imaging. Lumen 84 which is used to inflate theinner balloon 83 and create the gas column has an opening at a distalregion to communicate with inner balloon 83. A separate lumen 87 has anopening at a distal region to communicate with the outer balloon 82 tofill the outer balloon 82.

In use, catheter 80 is inserted into the uterus and stabilizing balloon85 is inflated to secure the catheter 80 in place and either blocksoutflow of dye or a plug is slid distally into position to block outflowof dye or a stationary plug is provided to block such outflow.) Thesystem is charged by inflation of the inner balloon 83, preferablypartially inflated for the reasons discussed above, by insertion of airthrough a side port which is in fluid communication with lumen 84 in aclosed system formed by the internal space of the inner balloon 83 andthe internal lumen 84 communicating with the internal space of innerballoon 83. Outer balloon 82 is filled, preferably partially inflatedfor the reasons discussed above, via injection of gas, e.g., air, orfluid, e.g., saline, through a separate lumen. With the outer balloon 82inflated, pressure monitoring can commence as external pressure appliedto the larger circumferential outer surface of the outer balloon 82compresses and deforms the outer balloon 82 which compresses the innerballoon 83. As the inner balloon 83 is compressed and deformed inresponse to compression/deformation of the outer balloon 82 based onchanges to uterine pressure resulting from dye injection, the sensor atthe distal end of lumen 84 provides continuous pressure readings,converted to an electrical signal by the transducer within the distalend of lumen 84, and then electrically communicates through wires 88extending through lumen 84 to an external monitor either directly or viaa converter. Although, the system is capable of continuous pressuremonitoring, it can also be adapted if desired for periodic monitoring sothe pressure readings can be taken at intervals or on demand by theclinician.

Note that although separate lumens are provided for the inflation ofinner balloon 83 and outer balloon 82, in an alternate embodiment, asingle lumen can be utilized to inflate both balloons 83 and 82. In suchembodiment, the catheter can have one less angled port and one lesslumen since inflation of the outer balloon would be through the sameport and lumen as the inner balloon.

The various sizes and shapes of the pressure balloons can be used in anyof the catheter embodiments. Note that larger or smaller pressureballoons, and larger or smaller stabilizing balloons, as well asdifferent shapes, can be used with the catheters of any of theembodiments described herein. Different shaped pressure balloons canalso be utilized such as those disclosed in U.S. application Ser. No.15/949,022, filed Apr. 20, 2018, the entire contents of which areincorporated herein by reference. Note the size of the balloons isprovided by way of example and are not necessarily drawn to scalecomparatively to the other components.

FIGS. 8-11 illustrate an alternate embodiment of the catheter of thepresent invention. The pressure balloon for detecting pressure, isdesignated by reference numeral 92. The outer balloon 92 functions inthe same manner as pressure balloon 26 of FIG. 1 so further discussionis not warranted. That is, the discussion of the compliant balloon 26 ofthe embodiment of FIG. 1, i.e., compression of the outer wall of theballoon compresses the air (or other gas) within the air (or other gas)lumen, is fully applicable to balloon 92 of catheter 90 of FIGS. 8-11.

Note in alternate embodiments, an outer balloon can be provided so thecatheter 80 would function like catheter 80 with balloons 82 and 83.That is, FIG. 8 shows the embodiment with a single pressure sensingballoon. However, the inner and outer balloons of FIG. 7A couldalternatively be utilized. In such embodiment, as discussed above withregard to FIG. 7A, contained within the compliant outer balloon is acompliant inner balloon providing a smaller diameter balloon and asmaller circumference (and volume) and communicating with the gas, e.g.,air lumen, to provide finer measurements as the outer balloon compressesthe outer wall of the inner balloon which compresses the air within airlumen.

The pressure transducer and pressure sensor are external to catheter 90and mounted to port 98 at the proximal end 90 a of catheter 90. Morespecifically, a transducer hub or housing, designated generally byreference numeral 100, contains the pressure transducer and sensor andis mounted to the angled side port 98. In the embodiment of FIG. 8, thehub 100 is mounted over the port 98 and can be locked or secured theretovia connector 110 such as by a snap fit, although other attachments arealso contemplated such as a friction fit, threaded attachment, a latch,etc. as well as other types of snap fits to provide an attachment thatmaintains an airtight seal so the air is contained within the air lumenand balloon 92. The hub 100 has an elongated (rod-like) member or nose102 extending distally therefrom (FIGS. 9-10B) through the extension 112of connector 110. More specifically, connector 110 is mounted to sideport 98 and has a distal housing 114 from which a pair of proximallyextending snap fit connector arms 116 extend. The arms 116 aresufficiently flexible to enable attachment and have an enlarged proximalportion, illustratively shown as arrow shaped although other enlargedshapes could be provided. The distal housing 114 has a lumen 118 forcommunication with the lumen in the side port 98 of catheter 90. Thelumen 118 also communicates with the lumen 119 in the proximal extension112 dimensioned to receive the elongated rod 102 of transducer 100. Thewire for the sensor extends in housing 100. Recesses 104 in hub 100 aredimensioned to receive arms 116 when transducer hub 100 is attached toconnector 110. Such attachment inserts the elongated rod 102 throughseals 115 a, 115 b into lumen 119 and 118 to advance air though the airlumen in the catheter and into the balloon 92. (Note the air lumenextends into its angled side port 98). The elongated member 102 also hasa channel 105 extending therethrough to allow the pressure wave totravel through to the pressure sensor. Although in preferred embodimentsno additional air needs to be injected into balloon 92 after attachmentof hub 100, it is also contemplated that a port or opening can beprovided in hub 100 to receive an injection device for injection ofadditional air. Such additional air can communicate with and flowthrough channel 105 of elongated member 102, into the air lumen andballoon 92 for inflation, or alternatively, a side port or opening inangled port downstream of the elongated member 102 could be provided.

To charge the system, when the hub 100 is mounted to the side port 98via attachment to connector 110, the elongated member 102 extends intolumens 118 and 119 to advance air through the air lumen into balloon 92(or the inner balloon in the embodiments with inner and outer balloons)to expand the balloon 92. That is, connection of the transducer hub 100to the catheter 90 (port 98) automatically advances air through thelumen to expand the balloon 92. In some embodiments, 0.2 cc of air canbe displaced/advanced by the member 102, although other volumes are alsocontemplated. Thus, as can be appreciated, mounting of the hub 100 tothe catheter 90 automatically pressurizes the air lumen/chamber andexpands the balloon. Note the balloon can be partially or fully inflated(expanded), dependent on the amount of air advanced into the balloon.Further note that the lumen is not vented to atmosphere when thetransducer hub 100 is attached and air is advanced through the airlumen. The port 98 can include a closable seal through which theelongated member 102 is inserted but maintains the seal when theelongated member 102 remains in the lumen 104. The seal can be providednear the entry of the elongated member 102 as in the dome shaped seal(valve) 115 b and seal (valve) 115 a.

The lumen which is used to inflate the balloon 92 and create the aircolumn has an opening at a distal region to communicate with theinterior of inner balloon 92. If an outer balloon is provided, anadditional lumen would be provided in the catheter to communicate withthe outer balloon to fill the outer balloon and an additional angledport (extension) at the proximal end of catheter 90 would receive aninflation device to inflate, either fully or partially, the outerballoon.

Note as in other embodiments disclosed herein, air is described as thepreferred gas for creating the column and expanding the pressureballoon, however, other gasses are also contemplated.

The balloons of the embodiments disclosed herein can be symmetricallyshaped as shown or alternatively shaped such that a distal region has anouter transverse cross-sectional dimension, e.g., diameter, greater thanan outer transverse cross-sectional dimension, e.g., diameter, of theproximal region. A smooth transition (taper) can be provided between thedistal region and proximal region, although other configurations arealso contemplated. The inner (and outer) balloon can by way of examplebe made of urethane, although other materials are also contemplated.

In the illustrated embodiment of FIG. 9, the wire connector can pluginto the openings of a connector positioned on or in the hub 100. Thewire connector can be internal of the hub with an opening in the wall ofthe hub to enable access for the wire connector. Also note thatalternatively the wire can include a female connector and the hub canhave a male connector. Other types of connectors/connections are alsocontemplated.

The catheter 90 can optionally include a slidable cork 95 for sealingthe uterine cavity or alternatively a sealing balloon such as thesealing and stabilizing (retention) balloon of FIG. 5A. The stabilizingballoon, as other stabilizing balloons disclosed herein, can be made ofsilicone, although other materials are also contemplated. If provided,the catheter 90 would have a lumen to inflate the stabilizing balloonand an additional angled side port in communication with the lumen forinjection of a liquid or gas to expand the stabilizing balloon. Theforegoing description of the stabilizing balloons is fully applicable tocatheter 90. Instead of a retention balloon (and the additional lumenand side port), a cork or plug can be provided to seal/prevent theoutflow of dye from the uterus which in some embodiments can be slidablealong the outer wall of the catheter. Catheter 90 also includes a lumenwith a distal side opening 90 b to provide for outflow of dye into theuterus as in the aforedescribed embodiments. In the illustratedembodiment, the opening 90 b is distal of balloon 92 (and distal of thestabilizing balloon if provided which is proximal of balloon 92. Inalternate embodiments, the side opening can be proximal of balloon 92(and distal of the stabilizing balloon if provided).

Thus, in the embodiment of FIG. 8, catheter 90 has two lumens: 1) alumen communicating with balloon 92 to inflate the balloon 92 and formthe air filled chamber; and 2) lumen 91 having a side opening 90 b at adistal end for injection of radiographic dye. Wires can exit from theair lumen of catheter 90 for connection to a pressure monitor via hub100. The catheter 90, as in the foregoing embodiments, can have anatraumatic tip 90 c.

In use, catheter 90 is inserted into the uterus and the cork 95 is movedalong the catheter to a sealing position. The system is charged byinflation of the balloon 92, preferably partially inflated for thereasons discussed above, by advancement of air through the air lumenupon attachment of the pressure transducer 100 to the connector 110 ofport 98 of catheter 90. Such attachment moves elongated member 102 intothe lumen to displace the air already in the lumen to expand the balloon92. A closed system is formed by the internal space of the balloon 92and the internal lumen communicating with the internal space of balloon92. In a preferred embodiment, additional air does not need to be addedto the balloon 92/lumen. With the balloon 92 inflated, pressuremonitoring can commence as external pressure applied to the balloon 92compresses and deforms the balloon 92 based on changes to uterinepressure, and the pressure sensor within the external hub 100 attachedat the proximal end of the catheter 90 provides continuous pressurereadings, converted to an electrical signal by the transducer within thehub 100, and then electrically communicates through a connector, e.g.cable 105, to an external monitor either directly or via a converter todisplay pressure readings. Although the system is capable of continuouspressure monitoring, it can also be adapted if desired for periodicmonitoring so the pressure readings can be taken at intervals or ondemand by the clinician. As noted above, preferably no additional airneeds to be added after mounting of hub 100. However, it is alsocontemplated that in alternate embodiments a port can be provided incommunication with hub 100 to enable subsequent injection of air throughthe lumen 96 into balloon 92.

In the aforedescribed embodiment, mounting of the transducer hubautomatically advances air through the first lumen to expand theballoon. In the alternate embodiment of FIG. 12, the pressure transducerhub 120 has a second elongated member 122 extending therefrom. Whentransducer hub 120 is mounted to the catheter, e.g., port 130, elongatedmember 102 enters the air lumen in the same manner as elongated member102 of FIG. 11 to inflate the pressure balloon. Additionally, elongatedmember 122 automatically enters the lumen at port 132 which communicateswith the outer balloon. Therefore, in this embodiment, the catheter hasan inner and outer pressure balloon and mounting of the transducer hub120 to the catheter a) automatically advances air through the firstlumen to expand the inner balloon; and b) automatically advances airthrough the lumen communicating with the outer balloon to inflate(expand) the outer balloon. Side port 134 can be provided to inflate astabilizing balloon if provided. Dye can be injected through lumen 136to exit a distal opening in the catheter.

FIGS. 13A-13D show an alternate embodiment of the hub/connector. Thepressure transducer is external to catheter 140 and mounted to port 142at the proximal end 141 of catheter 140 via connector (housing) 150.Catheter 140 is identical to catheter 90 of FIG. 8 except for theconnector and transducer hub temperature sensor connection.

More specifically, transducer hub or housing, designated generally byreference numeral 160, contains the pressure transducer and sensor 169and is mounted to the angled side port 142. In the embodiment of FIG.13A, the hub 160 is mounted to the catheter 140 by connection to housing150. Housing 150 is connected to port 142 via a barbed fitting 155providing an interference fit with the port 142. The hub 160 is lockedor secured to connector 150 such as by a snap fit provided by the latcharms discussed below, although other attachments are also contemplatedsuch as a friction fit, threaded attachment, other form of latch, etc.,as well as other types of snap fits to provide an attachment thatmaintains an airtight seal so the air is contained within the air lumenand balloon of the catheter 140. As noted above catheter 140 isidentical to catheter 90 except for its connector so catheter 140includes a pressure balloon, stabilizing balloon, temperature sensor,etc. The catheter 140 can also have an outer and inner pressure balloonas in the aforementioned embodiments.

The housing 150 attached to catheter 140 has a proximal opening 154 anda channel (lumen) 156 to receive an elongated (rod-like) member or nose162 extending distally from transducer hub 160. As shown channel 156 hasa first diameter region 156 a to match with the lumen 143 of the port142, a second larger diameter region 156 b proximal of region 156 a toreceive the male rod 162 of the hub 160, and a still larger diameterregion 156 c proximal of region 156 b to receive the valve 159 and valve158 and allow expansion thereof. As shown, valve 158 is dome shaped andis distal of valve 159. Conical cap 153, proximal of valve 159, providesa lead in to the valve 159 for the rod 162. Thermistor pins 152 receivethermistor connectors 168. Note valves 158, 159 are one example ofvalves that can be provided as other valves to provide an airtight sealare also contemplated. A single valve is also contemplated.

Hub 160 is mounted to connector 150 and includes a housing 164 fromwhich a pair of distally extending snap fit connector arms 166 extend.The latch arms 166 are sufficiently flexible to enable attachment andhave an enlarged distal portion 167, illustratively shown as arrowshaped although other enlarged shapes could be provided. The elongatedmember 162 extends between the latch arms 166. When the hub 160 ismounted to the connector 150, the elongated member 162 extends into thechannel 156 to advance air to inflate the inner balloon. The enlargedends 167 of latch arms 166 enter recesses 151 and engage shoulders 151 ato retain the hub 160. Note to release (disconnect) the hub 160, theends 167 are pressed radially inwardly to disengage from shoulder 151 aand the hub 160 is pulled proximally. Note that alternatively adifferent number of latch arms could be provided.

The housing (connector) 150 has a lumen 156 for communication with thelumen 143 in the side port 142 of catheter 140 which communicates withthe air lumen and pressure balloon of the catheter 140. As noted above,the lumen 156 is dimensioned to receive the elongated rod 162 oftransducer hub 160. The wire for the sensor extends in housing 160. Whentransducer hub 160 is attached to connector 150, such attachment insertsthe elongated rod 162 into lumen 156 to advance air though the air lumenin the catheter and into the pressure balloon. (Note the air lumenextends into its angled side port 142). The elongated member 162 alsohas a channel or lumen 165 extending therethrough to allow the pressurewave to travel through to the pressure sensor. Although in preferredembodiments no additional air needs to be injected into balloon 164after attachment of hub 160, it is also contemplated that a port oropening can be provided in hub 160 to receive an injection device forinjection of additional air. Such additional air can communicate withand flow through channel 165 of elongated member 162, into the air lumenand balloon 164 for inflation, or alternatively, a side port or openingin the angled port downstream (distal) of the elongated member 162 couldbe provided. Attachment of hub 1600 to housing 150 also automaticallyconnects thermistor connectors 168 to thermistor pins 152 toautomatically connect the temperature sensor to the hub 160 forcommunication via a cable to a temperature monitor.

To charge the system, when the hub 160 is mounted to the side port 142via attachment to connector 150, the elongated member 162 extends intolumen 156 to advance air through the air lumen into the pressure balloon(or the inner pressure balloon in the embodiments with an outer balloonover the pressure balloon) to expand the balloon. That is, connection ofthe transducer hub 160 to the catheter 140 (port 142) automaticallyadvances air through the connector lumen 156, the port lumen 143 and thefirst lumen 174 of the catheter 140 to expand the balloon. (Suchconnection also automatically connects the temperature sensor to the hub160). In some embodiments, 0.2 cc of air can be displaced/advanced bythe member 102, although other volumes are also contemplated. Thus, ascan be appreciated, mounting of the hub 160 to the catheter 140automatically pressurizes the air lumen/chamber and expands the balloon.Note the balloon can be partially or fully inflated (expanded),dependent on the amount of air advanced into the balloon. Further notethat preferably the lumen is not vented to atmosphere when thetransducer hub 160 is attached and air is advanced through the airlumen. The port 142 includes a closable seal, e.g., valves 158 and 159,through which the elongated member 162 is inserted but maintains theseal when the elongated member 162 remains in the lumen 156. Note thatcatheter 140 is identical in all other respects to catheter 90 so thatthe description of catheter 00 and its components and function (andalternatives) are fully applicable to catheter 140, the difference beingthe connector 150 of catheter 90 to receive transducer hub 160. Thetransducer hub is also different, e.g., has latch arms and a differentconfiguration.

Additionally, in alternate embodiments, any of the catheters disclosedherein can include a channel (lumen) for sensors for measuring differentparameters and their associated wires (unless wireless) can be providedin separate channels, or alternatively, one or more sensors and theirassociated wires can be provided in a single channel to reduce theoverall size/diameter of the catheter.

It is also contemplated that a backup system be provided to determinepressure. The backup system can provide a double check of pressurereadings to enhance accuracy. Such backup system can be used with any ofthe embodiments disclosed herein to provide a second pressure readingsystem. One example of such backup system has a pressuretransducer/pressure sensor like sensor 30 of FIG. 1 within the air lumencommunicating with the pressure balloon, forming a “first system”, plusa pressure transducer/pressure sensor at a proximal end of the catheteras in FIG. 6 or external of the catheter forming a “second system”.Thus, the pressure sensor is at a distal end of the air charged lumenand a pressure sensor is at proximal end of the air charged lumen. Bothsensors are electrically connected to a monitor that provides a graphicdisplay of pressure readings. A stabilizing balloon and an inflationlumen to inflate the balloon and/or a proximal plug can also beprovided. A lumen provides a passage for dye in the same manner as lumen20 of the embodiment of FIG. 1. In such embodiments, with the ballooninflated, pressure monitoring can commence as external pressure appliedto an outer surface of the balloon compresses the gas, e.g., air, withinthe chamber. The sensor at the distal end of the lumen providescontinuous pressure readings, converted to an electrical signal by thetransducer within the distal end of lumen, and then electricallycommunicates through its transmission wires extending through the air(or other gas) lumen to an external monitor either directly or via aconverter. Additionally, pressure within the air (or other gas) chargedcolumn is measured at a proximal region by a sensor within or mounted toa side port of the catheter. The sensor at the distal end of lumenprovides continuous pressure readings, and such pressure readings can beconfirmed by the proximal sensor. Such pressure readings can beperformed continuously or alternatively can also be adapted if desiredfor periodic monitoring so the pressure readings can be taken atintervals or on demand by the clinician. Thus, air (or other gas)pressure readings at a proximal end plus microtip pressure readings atthe distal end are provided. The sensors can electrically communicatewith an external monitor to display both pressure readings from sensors,or alternatively, if the pressure readings are different, they can beaveraged to display a single measurement. Clearly, other displays ofinformation can be provided to display the information from the twosensors.

The sensors disclosed herein can be microtip sensors within the airlumen or balloon. In alternative embodiments, fiber optic sensors withinthe air lumen or within or around the balloon can by utilized totransmit circumferential/area pressure exerted on the uterus. Thepressure transducers can be housed within the catheter or alternativelyexternal to the catheter.

Thus, these catheters provide a closed system. The catheters also have aballoon providing a large reservoir (large capacity) and largecircumferential area/interface for obtaining more information from theuterus over multiple reference points (rather than a single pointsensor) that provides an average pressure to provide a gross measurementand a more accurate assessment of the surrounding environment aspressure measurement is not limited to one side of the uterus but candetermine measurements on the opposing side as well.

As noted above, the catheters, i.e. the transducer, can be connected toa bedside monitor or a handheld monitor providing a portable readoutthrough either a wire or blue-tooth wireless connection. Such wirelessconnection would provide the patient the option to ambulate while inlabor. The monitor can be provided as a kit with one or more catheters.

The system can also include an indicator or alarm system to alert thestaff at the site as well as remote staff through wired or wirelessconnections to external apparatus, e.g., hand held phones or remotemonitors.

As noted above, an alarm or indicator can be provided in someembodiments to alert the staff. The indicator can be a visual indicatorsuch as a light, LED, color change, etc. Alternatively, or additionally,the indicator can be an audible indicator which emits some type of soundor alarm to alert the staff. The indicator can be at the proximal regionof the catheter or at other portions of the catheter, e.g., at a distalend portion, where known imaging techniques would enable the user todiscern when the indicator is turned on. It is also contemplated that inaddition to providing an alert to the user, the pressure or othermonitoring system can be tied into a system to directly controlparameters so that if the pressure or other parameter is outside adesired range, appropriate steps can be taken such as for examplecontrolling the infusion of dye. In such systems, one or more indicatorscan be provided on the proximal portion of the catheter, e.g., at aproximal end outside the patient's body, or separate from the catheter.The sensor(s) is in communication with the indicator(s), either viaconnecting wires extending through a lumen of the catheter or a wirelessconnection. The sensor(s) can be part of a system that includes acomparator so that a comparison of the measured pressure, or otherparameter, to a predetermined value is performed and a signal is sent tothe indicator to activate (actuate) the indicator if the measuredpressure value or other value is exceeded, thereby alerting theclinician or staff that pressure or other parameters are outside desiredranges and a signal is also sent to a device or system to automaticallyactuate the device or system to make the necessary adjustments. If themeasured value is below the threshold, the indicator is not activated.It is also contemplated that microtip sensors and/or fiber optic sensorscan be utilized to measure pressure, and these sensors can be utilizedinstead of the air pressure readings utilizing the aforedescribedballoon(s) for measuring pressure.

Although the apparatus and methods of the subject invention have beendescribed with respect to preferred embodiments, those skilled in theart will readily appreciate that changes and modifications may be madethereto without departing from the spirit and scope of the presentinvention as defined by the appended claims.

1-13. (canceled)
 14. A multi-lumen catheter for monitoring intrauterinepressure to prevent damage to the fallopian tubes of a patient whiledetermining patency, the catheter comprising an elongated bodyconfigured and dimensioned for insertion into a uterus of a patient, thecatheter having a first lumen, a second lumen and a pressure sensor, thesecond lumen having an opening within in communication with the uterusfor injection of dye or other fluid out of the opening and into theuterus to assess a condition of the fallopian tubes, the pressure sensormonitoring pressure within the uterus to thereby assess if pressurebeyond a predetermined pressure is being applied to the fallopian tubesof the patient in response to the injection and condition of thefallopian tubes.
 15. The catheter of claim 14, wherein the catheterfurther comprises a pressure balloon for monitoring pressure, a thirdlumen and a blocking balloon, the third lumen communicating with theblocking balloon to inflate the blocking balloon to block outflow of dyeand retain the catheter, the blocking balloon having a diameter greaterthan a diameter of the pressure balloon.
 16. The catheter of claim 14,further comprising a stopper on an external surface of the catheterslidable with respect to the catheter to stop outflow of dye.
 17. Thecatheter of claim 14, wherein the pressure sensor is positioned in adistal region of the first lumen, and at least one wire extends from thesensor proximally through the first lumen for electrical communicationwith an external monitor. 18-20. (canceled)
 21. The catheter of claim14, further comprising a pressure balloon, the pressure balloondeforming to compress gas within the balloon for monitoring pressure.22. The catheter of claim 21, further comprising an outer balloonpositioned over the pressure balloon, the outer balloon deforming todeform the pressure balloon
 23. The catheter of claim 21, wherein thepressure balloon is partially inflated to receive less than a maximumvolume for pressure measurement.
 24. The catheter of claim 14, whereinthe pressure sensor is positioned external of the catheter.
 25. Thecatheter of claim 21, wherein the pressure balloon is positionedproximal of a distal tip of the catheter.
 26. The catheter of claim 14,wherein the sensor continuously communicates with an external monitor tovisually display pressure readings to indicate based on intrauterinepressure if excess pressure is being exerted on the fallopian tubes ofthe patient.
 27. The catheter of claim 14, further comprising a balloon,wherein the pressure sensor is connectable to the catheter andcommunicates with a gas filled chamber within the first lumen of thecatheter for measuring intrauterine pressure based on gas compressioncaused by deformation of the balloon.
 28. The catheter of claim 27,wherein the gas is air and the pressure transducer is contained within ahub, and connection of the hub to a first port of the catheterautomatically advances air into the balloon to expand the first balloon.29. The catheter of claim 28, wherein the first lumen is not vented toatmosphere when the hub is connected to the catheter and advances air toexpand the balloon.
 30. A method of assessing a condition of fallopiantubes of a patient and measuring uterine contraction pressure whileassessing the condition, the method comprising the steps of: providing acatheter having a first lumen; inserting the catheter into a uterus of apatient; injecting a dye or other fluid through the catheter into theuterus to assess the condition of the fallopian tubes; obtaining a firstpressure reading of the uterine contraction pressure; and transmittingthe first pressure reading to an external display connected to thecatheter to indicate the pressure reading.
 31. The method of claim 30,further comprising a compressible balloon for compressing gas within thefirst lumen in response to pressure exerted on the balloon.
 32. Themethod of claim 31, further comprising a step of connecting a hubcontaining a pressure transducer to the catheter to automaticallyadvance air through the first lumen of the catheter to expand theballoon from a deflated condition to a more expanded condition.
 33. Themethod of claim 32, wherein the catheter includes a temperature sensor,and the step of connecting the hub automatically connects thetemperature sensor to a connector within the hub.
 34. The method ofclaim 33, further comprising the step of measuring one or both of fetalheart rate and maternal PO2 levels.
 35. The catheter of claim 30,wherein the catheter further comprises a pressure balloon, a third lumenand a blocking balloon, the third lumen communicating with the blockingballoon to inflate the blocking balloon to block outflow of dye andretain the catheter, the blocking balloon having a diameter greater thana diameter of the pressure balloon.
 36. The catheter of claim 30,further comprising the step of sliding a stopper on an external surfaceof the catheter to stop outflow of dye.